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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00818649 |
RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: bortezomib Drug: vorinostat Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Velcade Plus Vorinostat in the Treatment of High Risk MDS and Relapsed/Refractory AML |
Estimated Enrollment: | 46 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral vorinostat once daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response, partial response, or hematologic improvement may receive 3 additional courses of therapy (for a maximum of 6 courses).
Bone marrow and peripheral blood samples are collected at baseline, on day 15 of course 1, and at the completion of 3 courses of therapy for analysis of target cells (myeloid blasts) (i.e., HLA class I receptor analysis and natural killer [NK] cell receptor ligand analysis) and analysis of activating NK cell receptor alterations and NK-mediated cell killing.
After completion of study treatment, patients are followed periodically for up to 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of one of the following:
Myelodysplastic syndromes meeting any of the following criteria:
Acute myeloid leukemia, including histologic subtypes M0, M1, M2, M4, M5, M6, or M7, and meets 1 of the following criteria:
Newly diagnosed or untreated disease
Must have stable bone marrow function for > 7 days prior to study entry
No active CNS disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 2 weeks since prior treatment for myeloid disorder, including chemotherapy, hematopoietic growth factors, or biological therapy (e.g., monoclonal antibodies)
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Principal Investigator: | Erica Warlick, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( Erica Warlick ) |
Study ID Numbers: | CDR0000630472, UMN-2008LS044, 2008-06R, 0808M44081, MILLENNIUM-X05269 |
Study First Received: | January 7, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00818649 |
Health Authority: | Unspecified |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory anemia with excess blasts adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute minimally differentiated myeloid leukemia (M0) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) |
adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Leukemia, Monocytic, Acute Precancerous Conditions Refractory anemia Acute myelomonocytic leukemia Leukemia, Myeloid, Acute Di Guglielmo's syndrome Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Myelodysplastic syndromes |
Hematologic Diseases Bortezomib Vorinostat Myelodysplastic Syndromes Myelodysplasia Anemia Acute myelogenous leukemia Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Acute monoblastic leukemia |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions Protease Inhibitors |
Neoplasms Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Syndrome Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |